- PMP and Scrum Master Certified senior Project/Program Manager with solid experience in flawless execution of diverse projects in technology, infrastructure, change management and strategic re - organization.
- Accountable with various roles as a Program Lead, Project Manager, Business Analyst, Development Manager, Application Architect, Systems Lead, Techno-Functional Lead, and Deployment Lead.
- Experience with SaaS and Cloud Software Application development.
- Active partnership, strategic vision development, and change leadership role with executives, PMO, and management in high-visibility projects. Developed and executed measurable strategic services roadmaps.
- A change agent with Confidential and business competencies within companies of small (<100) to large (>100,000) size across USA, Asia, and Europe.
- Key player in strategic and tactical planning, organizational decision making, business development, project delivery, people management, leading cross functional teams and implementing successful offshore model, feasibility study, formulating proposal, client expectation management, project justifications (business case), RFP’s, capacity planning, managing schedule, cost/budget, scope, risk, issue and resources, vendor management, defect management and change control management.
- Championed several complex projects (up to $5MM USD, and 30+ team size) across multiple technologies and platforms, by leading and collaborating with senior business and technology stakeholders, teams and vendors across continents for 12 plus years.
- Business case ideation from the demanded changes in M&A, organization restructuring, and globalization of business processes integrations. End-to-end accountability for operational support, delivered results through strategic alignments between business thinking and Confidential roadmap constructions. Delivered value-based effective Confidential capabilities, cross-functionally aligned with process-refining Kaizen, and Scrum practices.
- Built Confidential strategies in by working along-side senior executives, and key business stakeholders in multinational companies, in order to define Confidential roadmaps for sustainable and business-valued outcomes through effective capabilities delivered over 18 plus years.
- Directed in traditional SDLC projects for GxP-CSV, and non GxP using Waterfall and Hybrid approaches, where clearly defined plans were outlined at the onset, to manage software systems capabilities, adhering with regulatory and compliance guidelines.
- Negotiated global contracts, and support services management (RFI, RFP, SOW, MSA, SLAs, and software licensing agreements), with budgets <$2MM - $12 MM USD annually. Awarded multinational S/W service re-agreements, bringing additional TCO savings.
- Delivered effective outcomes in R&D Confidential PMO establishment aligned with the corporate PMO. The results were: improved project intake reviews, effective prioritization, new tools, templates and methodology for PMs; cost efficiency gains; increased dash-board visibility on projects, raising the bar for project management practices.
- SQL Server
- Clients Server
- VBA and PL/SQL
- Unix dot Net
- Visual C+
- Incidents/bugs/change/test tracker
- Service Now. SDLC
- IS methodology for CSV projects (GxP)
- Confidential audit
- Change Control Management compliance mgmt.
- PMO establishment and BPM. Informatica and TIBCO-Spotfire
- Power Point
- MS Project
- HP PPM
- COTS in Laboratory Systems
- Confidential consultant project management role, directed in several validated systems Confidential projects, utilizing AWS cloud-based SaaS, and PaaS, in a heavily matrixed setup (USA, India, and Japan).
- Architected hybrid cloud solutions for financial services using cloud-based focused on fraud preventions through security frameworks: Agile methodology thought leader with multiple sprints.
- Provided leadership in generating cross product and project task plans, resource planning, identifying interdependencies and risk management plans utilizing AWS cloud-based SaaS, and PaaS, in a heavily matrixed setup (USA, India, and Japan).
- Managed project budgets in excess of $4M as well as procurement activities for Enterprise Project Management Office (EPMO); organized and led technical, clinical, and administrative resources.
- Re-architected multi-tiered web-based SaaS application to improve scalability, performance; automated scaled deployment to AWS cloud.
- Managed requirement gathering, designing, coding, and test driven development initiatives handling both offshore and onshore team members. Coordinated and managed code releases with DevOps Team.
- Hands-on writing and leading RFP, SOW, proposal presentation creation and value proposition storytelling at CXO level.
- Worked closely with VP of Confidential to establish Confidential PMO department to collaborate with ePMO to prioritize and manage all on-going projects to minimize Confidential resources conflict. Negotiated with stakeholders to align products roadmap with Project Delivery Team (PDT) schedule. This resulted in a cohesive and collaborative team.
- Worked with customers and Confidential resources, estimation on demands collected through the customer engagement leads.
- Worked as a Product Development Lead for software supporting CSV automation and reporting for medical devices.
- Marketing promotion, and product improvement liaison for a software designed to speed-up and semi-automate clinical study set up and data management.
- Lead new technology and service innovation initiatives. Develop new levels of product delivery and service quality. Plan and execute technology proof concepts, pilots, and adoption strategies. Develop strategic plans and service delivery improvement initiatives with senior management and executives. Optimize systems, enhance auditability, and increase technology ROI. Re-architect application development and management.
- Executed the project plans and schedules, which included managing the day-to-day project operations, identifying required resources, assigning individual responsibilities, tracking and managing project budget and schedule, and providing effective timely communications to all stakeholders, effectively applying PM best practices and standards, all of which ensured the move's success.
- Evangelized and cultivated Agile principles of collaboration, prioritization, financial fraud detection, intelligence analytics, team accountability and visibility; ensured consistent application of scrum methodologies across the enterprise.
- Facilitated scrum ceremonies (sprint planning, daily stand-up meetings, reviews, retrospectives, release planning, demos and other Scrum-related meetings).
Program Leader & Lead Business Consultant
- Implemented 2 new services for the portfolio comprising of 20 plus systems. Result: Improved dashboard visibility for portfolio service and demand management.
- Led efforts to design a Data Governance framework, policies and organization. Develop data standards, Metrics and Measurement. Data Protection and data archiving.
- Secured portfolio service adoption, financial forecasting and budgetary accountability for USA and Europe, mobilized resources for on /off-cycle business, and Confidential opportunities for Confidential systems’ portfolio assessments and operational support.
- Led senior engineering, development, and business teams in advanced 24x7x365 infrastructure, virtualization, high-performance computing (HPC), scale-out/scale-up, projects for development and delivery of commercial genomics products. Promoted and led active collaboration with software engineering, business development, and customer services teams to continuously enhance products and customer service. Re-align service portfolio to new business strategy and growth. Developed global technology service delivery and capacity models for USA and Europe. Result: Enhanced service visibility and improved customer experience with high availability on two time-zones across Europe, and USA.
- Architected the design of data-factory builds, Common Nomenclature Repositories design, in fulfilment of short-term gaps while defining long-term data-flow integration strategy. Result: Pre-requisites done for the integration of work-streams, clear isolation of redundant and higher TCO systems for replacement/ retirement, enhancement gaps analyzed for interdependent systems (producer and consumer) in order to define technology roadmaps of visual analytics and KM solutions across discovery value chain.
- As a Project Manager, directed several projects in parallel, ranging from >$100K to $5MM US Dollars (Agile and Waterfall SDLC, 6 months to up to 2 years length) replacing local-workflow Confidential systems with COTS products, new and custom technology product for patent filing, and in-house supply order management/logistics capability/tool for external material requisitions and payments, used by scientists in 4 countries.
- Negotiated and awarded multi-year contracts for COTS licensing (>$3MM USD), and support (>$200-400K USD) while working alongside procurement and legal in order to reduce overall TCO, while stretching the use of, and defined better exit strategies.
- Mentored and coached line-managed team staff (9 direct) in USA, Germany, and Austria for soft skills development, such as: improve upon communications, higher business interactions and visibility of technical staff, fostering global service mindset, and implemented cross-site support during business operation hours across 2 continents, promoted best-practices in software development (Agile coaching), and product service management through service desk, while promoting existing PMO processes.
- Designing Architecture, Evaluating Products, Procuring, Installing and implementing the system. Gained Extensive Hands on Experience with several scientific modeling, and logistics tools developed using dot Net, Java, and Oracle products.
IT Alliance management PM Consultant
- Provided Solution Designs for enterprise applications and participated in the Solution Design and Project Delivery process.
- The PIM is a GxP validated system. The Quality stakeholders were embedded in the Confidential team to participate throughout the SDLC and help the validation process and documentation required for Confidential . Risk Assessments, User requirements, FRS, Requirement Traceability Matrix (RTM) IQ/OQ/PQ protocols and validation summary report (VSR) were implemented as part of project.
- Lead efforts lay down a Data Governance framework, policies and organization. Develop data standards, Metrics and Measurement. Data Protection and data archiving.
- Developed Change Control procedures, communicated information to upper management, facilitated meetings and documented decisions.
- Created and updated SOP's and work instruction for Business and Confidential groups to comply with validated systems requirements. Drove meetings to review SOPs, and coordinated approval of SOPs.
- Collaborated with other technical areas to integrate support across tiers, platforms and areas of responsibility as well as with our Outsource Partner.
- Lead project planning sessions to ensure the feasibility of implementation milestones.
- Mentored staff and provided model for maintaining best practices in project and process management, coaching of team members and key stakeholders regarding organizational change management activities to gain alignment within the organization.
- Established foundation of PMO methodology following PMA and PMG guidelines, ITIL v3.0 guidelines for change management, portfolio management, and fiduciary management. The creation of the PMO included the ability to track resources, projects, and implement policies and procedures. Knowledge of spend enabled firm to operate more lean with less waste, manage resources and projects more efficiently and effectively.
- Worked closely with the business and Confidential leadership, using my SME, and my global relationship management skills. Collaborated with winning mindset, through transparencies in timely and multi-channel communications across several geographies, brought effective outcomes from tasks-undertaken, in order to maintain trusted advisor status for influencing decisions, and brought result with or without direct authority.
- Lead projects in various areas, with COTS products for conformity compliance, CAPA deviation reporting, LIMS, ELNs, SharePoint based LMS, and Lab-data management and more to support the predictive and statistical modeling, data retention, reporting, and auditing needs.
- Compliance to FDA and other regulatory agency predicate rules, GAMP 5, 21 CFR Part 11, EU Annexure 11 rules, and company procedures.
- In all phases of software development life cycle (SDLC).
- Managed the technical architectural design for a small scale manufacturing laboratory building effort (equipment scheduling and requirement management, communication and booking management, charge-back management in support of laboratory logistics automation.
- Spearheaded assessment of Operation processes, resulting in shorter deliver cycle.
- Responsible for scheduling, planning & prioritizing, estimations, client and stakeholder management, tracking and reporting, issues and risk management. Working with team and providing technical & process based inputs to come up with solutions. Managed Retrospective Capture and Closure: defined, implemented and re-visited the validation for instrument data collection and network retentions (Collaborative Approach for SOP development).
- Developed various validation-related documentation primarily for a COTS system and its associated modules and drivers, which included standardizing documentation formats and templates to establish change control methodology.
- Manage large, complex projects to revitalize and continuously improve global quality manufacturing applications. (Document and label control systems, reliability engineering laboratory management systems, product experience, in-process monitoring to facilitate change management within on-going batch synthesis, and regulatory reporting systems)
- Work with business and Confidential management to establish project goals, objectives, deliverables, schedules, cost estimates and resource allocation. Manage project activities through the project lifecycle, ensuring all deliverables are achieved.
- Directed in technical assessments, and enablement of EDI and collaboration workspace for DROs and CROs in the U.S. and abroad. Result: Minimized re-work on data input, ensured IP and data privacy, yet enabling DMZ-mocked interfaces for the service providers.
- Managed the 1st Chemistry registration, and Bio-assay repository COTS rollouts for Lab. Electronic Data Capture capability with data standards, and minimally required data guidelines set-up to enable 100% data collection via automation, cutting transformation errors, and capturing 80% of the requirements upfront, for data analysis. Awarded licensing contracts up to $150k, consulting with procurement and legal, reducing total cost by more than 50% in the 1st year. Result: Establishment of a single-pair foundation system.
- Learning management of a 3rd party Confidential service provider to onboard with flexible-staffing model /outsource Clinical data and systems management. Result: Planned reduction of the fixed Confidential FTE, improved ramp-up, and ramp-down for clinical studies/trials.
- Directed in a new initiative by the R&D Confidential Leadership team to implement a project and portfolio management application (HP PPM) spanning 250 users sponsored directly by the CIO and department VPs. The project was to help improve forecasting accuracies, reporting, and resource tracking.
- Effectively ensured standard processes were monitored and followed (e.g. Service Strategy, Design, Transition, and Operation and Continual service improvement).
- Ensured adherence to quality standards, timely delivery of complex projects and achievement of financial objectives. (Budgets, scheduling, approval of all expenditures, variance analysis and corrective actions).
- Created project plans in MS Project, requirements document, deliverables and milestones in Project Server. Created project plans according to SDLC methodology.
- Liaison with the business to get requirements and update them on the status of the project
- Collaborated with the vendor to clarify requirements, manage their scope and resources.
Senior Confidential Project Manager
- Directed multiple projects retiring legacy systems, Data governance and capabilities delivery, data engineering (inspecting, cleaning, transforming, and modeling data), integrated glossary management system, research Data warehouse, visual analytics tool integration, annotation system P-o-C, and enabling COTS reporting tools across R&D sites in the USA, and Europe. Utilized several innovative technologies, in the company to achieve desired outcome with HPC (high performance cluster computing), and R&D computational science groups. Delivered through innovative solution-ing, during and out of budget-cycle requests from business.
- Performed cross-project collaborations to integrate work-flows from disparate data sources dating back 30-plus years, via systems integrations. Net cost savings projected was at least $12 MM USD in ROI (18 months, 2 vendors, 5 direct, and 30 matrix resources). Line management of Confidential staff in USA, and Europe.
- Led in the R&D Confidential PMO establishment aligned with corporate PMO. Result: Improved project intake scrutiny, effective review and prioritization, new tools, templates and methodology establishment; cost efficiency gains; increased dash-board visibility of project health, raising the bar for SDLC project management practice.
- Led in infrastructure service outsourcing, data center and infrastructure migration, and helpdesk establishment for scientific application support, programs ranging >$10 MM USD. Result: Reduction in support cost; standards implemented for hardware architecture; and technology consolidations; improved utilization of internal staff to focus on new technologies evaluation, and deployment.
- Provided feedbacks to help re-evaluate several software services contracts, SW vendor audits, SLA, MSA amendments, and awarded several SOW contracts across USA, Europe, and Asia for demand fulfilment for the global operations with budgetary responsibilities over nine years. Savings of several $ MM dollars after the merged company was able to consolidate licensing and service structure at the global scale.